# K240761: Arisure® Closed Male Luer with Spike Adapter (YM060)

- Pathway: 510(k) (Traditional)
- Applicant: Yukon Medical, LLC
- Decided: Mar 21, 2025 after 366 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K171101 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171101: Closed Male Luer, Yukon Medical (2017) Summary page 6.

## Indications for use
The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

Source page: https://510kreport.com/device/K240761
Methodology: https://510kreport.com/methodology